drugset / Trial / NCT01168336

Evaluation of Co-Administration of Betahistine as Adjunctive to Olanzapine in Healthy Subjects

NCT01168336

Phase 1 Completed 90 enrolled OBEcure Ltd.
RandomizedParallel-groupTriple-blind

Summary

The study aims to evaluate the safety and pharmacokinetics of extended release and standard formulations of betahistine when administered as monotherapy and as compared to their safety and pharmacokinetics when co-administered with olanzapine and to determine potential dose limiting toxicities and/or drug-drug interactions affecting the pharmacokinetics or safety of either medication, with particular emphasis on somnolence and weight gain secondary to olanzapine treatment

Timeline

Start
2010-07
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Betahistine Small molecule 24 mg
Subject Betahistine Small molecule 32 mg

Indications

No indication recorded.